Technical File for the Vein-Eye® Carry medical device Table of contents Page(s) General information concerning the structure and use Safety, testing, certification Tariff Commodity Code, Country of Origin, Input power Explanation of NIR wavelengths 2, 3 4 5 6 Photographs of components Photographs and list of applicable standards List of components Packaging specification 7, 8, 9, 10 10 12 12 Sub- assembly drawings, circuitry and QA (e.g., QC specs, in-process and end-controls, end-release etc.
General information concerning Near Infrared Imaging (Company) and the Vein-Eye Carry (VEC). Near Infrared Imaging (Company) incorporated in the State of Delaware in 2013. Company address: PO Box 264, Wrentham, MA, 02093, USA Telephone: (Tel) 1 - 508- 384-3800. Email: info@nearinfraredimaging.com Website: https://nearinfraredimaging.
The Vein-Eye CARRY only weighs less than 10 lbs. and can be carried into the home, throughout the hospital or nursing home, used in an ambulance and carried into remote villages and towns. There are 40M vein punctures everyday worldwide and 20% fail on the 1st attempt. Care delays occur in approximately 25% of all patients regardless of care setting due to the inability to establish IV access.
Safety, testing and certification. EC declaration of conformity and classification to 93/42/EEC annex IX According to the Council Directive 93/42/EEC, the Vein-Eye Carry is a Class 1 medical device and conforms to 93/42/EEC annex 1X. The Vein-Eye Carry is non-contact, noninvasive, low voltage, minimal risk, and does not need to operate in a sterile environment. The Vein-Eye Carry has been tested and certified as safe.
Input: 100-240VAC, 0.5A, 50/60Hz, Output: 5VDC, 3000mA; 9VDC, 2000mA; 12VDC, 1500mA (Specified Power Supply P/N: XY18W1204-PD) Equipment Rated 12Vdc, 1.9A, 22.8W STANDARDS: IEC 60601-1:1988 + A1:1991 + A2:1995 Country of Origin: USA The Tariff Commodity Code (Harmonized International Code): 9006.30 The VEC uses a Class 1 laser. A Class 1 laser is considered to be incapable of producing damaging radiation levels and is therefore considered safe under normal working conditions.
The design of Vein-Eye Carry-VEC03 is based on the principle that the blood will absorb near-infrared light and the tissue around the vein does not. This makes the images of the veins appear darker than its surrounding tissue, this makes easier to seethe vein map by the healthcare professionals. The Near Infrared (NIR) camera emits wavelengths in the 850 nm range. The NIR light is projected onto a patient’s skin and penetrates the body anatomy.
Vein-Eye Carry (VEC 03) system includes 6 key components. 1) The near infrared camera 1080p USB 3.
2) Quick Wall Charger Quick PD 3.0 18W Charger Input: 100-240VAC 0.5a 50/60HZ Quick Full Charge Time: 2.5 hours UL approved 3) Gooseneck: Flexible and versatile mounting gooseneck for cameras. a. Holds up to 3 Lbs.
4) Super Clamp: Standard Stud: 1/4 & 3/8 Inch, Weight: 0.9lbs, holds up to 33lbs Attachment: 16mm Hexagonal, 1/4 Inch Threads Attachment Type Material: Die-Cast Meta Gooseneck tube with super clamp and camera 5) Tablet with laptop sleeve Windows 10 with proprietary video enhancement software 10.1 ” IPS full screen 1920 X 1200 (FHD) with USB 3.0 port CPU: Intel Celeron N4500 Core: 2 cores, 2 threads, 1.1GHz-2.
6) Carrying case Customized hard-shell case for traveling 16” X 11.4 × 5” Comes with an adjustable strap to carry the case with the handle or with the shoulder strap.
List of components Part Description QTY IR Camera (850nm) with USB cable 1 Gooseneck tube 19” 1 Super Clamp 1 Wall Charger 18W USB Type-C 2 Carrying Case: 16” length X 12” width X 6” Height 1 Product Label 2 10-inch Tablet (1920x1200) with laptop sleeve 1 12” X 10” X .50 (1/2”) packing foam 2 Packaging specification ➢ Place the flat foam on the bottom of the carrying case.
Sub-assembly drawings, drawings of components (circuitry) QA specification (e.g., QC specs, in-process and end-controls, end-release etc.) ➢ All cameras are 100% tested before shipment. ➢ Near Infrared Imaging’s managers and engineer check the performance of the product every month to guarantee that there no loss of performance.
Labelling, accompanying documents, package insert Labelling is on the camera, on the Tablet, and on the carrying case. Description about the creation of a Lot or Charge No. It is based on the customer order. Instructions for use (e.g., EN 1041) Please refer to the separate End User Assembly and User Guide Intended / clinical use The Vein-Eye Carry is a hands-free and portable medical device that helps medical professionals locate superficial veins.
Product verification Our product verification process ensures that the product conforms within the design specifications. Testing data and reports, functionality studies, wet lab or bench top testing The Testing data and report by Intertek is in Attachment B. In addition, Sparqtron tests each component of the system and the entire system prior to shipping. EMC testing and certificates The Vein-Eye Carry has been tested by certified by Intertek based on IEC6061-2 safety standards. See Attachment B.
Power and battery information Tablet power: Battery: 22.42W, 7.
• The VEC technology penetrates layers of fat, hair, moisture and skin color to provide accurate real-time images of veins in every patient. The company uses customer feedback as a means of product validation. This has been very helpful to improve our technology and to streamline development. Validation of the packaging/ageing studies The product packing is based on the dimension and weight of our product, which allows ease of use and carry for our customer.
System parameters Height: Weight: Width: Operating Transport Storage 6” Without accessories 2 With accessories 4 lbs. Without accessories 6 lbs. With accessories NA Temperature 3.9°C to 40.5°C (39.02°F to 104.9°F) Humidity 5.1% to 86% RH non-condensing Temperature -19.5°C to 51°C (-3.1°F to 123.8°F) Humidity 4.9% to 86% RH non-condensing Temperature -21°C to 51°C (-5.8°F to 123.8°F) Humidity 4.
Attachment A (18)
Test Report issued under the responsibility of: IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance Report Reference No........................: 104473702BOX-001 Date of issue.....................................: 17-November-2020 Total number of pages......................: 97 CB Testing Laboratory......................: Intertek Testing Services N.A. Inc. Address..............................................